MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

Device Description

The MLI Soft Tissue Screw and Washer System is an assembly unit consisting of MLI Soft Tissue Anchoring Screws and MLI Washers. The screws are provided in standard sizes (4.5 mm Cortical and 6.5 mm Cancellous) and conform to ISO 5835. They are self-tapping and inserted manually with a 3.5 mm hex driver. The washers are universally compatible with both screw sizes and come in three design configurations (Round, Triangular, Oval) with spikes on the distal side to penetrate bone and anchor the graft.

AI/ML Overview

This is a premarket notification for a medical device (MLI Soft Tissue Screw and Washer System), not an AI/ML-powered device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the MLI Soft Tissue Screw and Washer System to predicate devices through mechanical testing. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state numerical "acceptance criteria" for the MLI device. Instead, it aims to demonstrate substantial equivalence by showing that the MLI screw/washer constructs performed "as well or better than" the predicate screw/washer construct in yield load tests.

Test Description	Acceptance Criteria (Implied)	Reported Device Performance
Fixation strength (Yield Load) of various MLI screw/washer configurations in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model (Tests #1, #2, #3, #4)	Performance (yield load) must be "as well or better than" the currently marketed predicate screw/washer construct.	"When the yield load results for the various MLI Soft Tissue Screw and Washer System screw/washer constructs were compared to the currently marketed screw/washer construct, the MLI screw/washer constructs all performed as well or better than the predicate screw/washer construct."
Mode of failure for all MLI Screw and Washer configurations	Mode of failure should be similar to published results for ligament anchorage to an implant (i.e., ligament pulling out from under the washer).	"The mode of failure for all MLI Screw and Washer configurations was similar for all screw/washer constructs tested, wherein the ligament pulled out from under the washer. The modes of failure are also consistent with results obtained by Matthews et.al and Kurosaka et.al where the site of failure was at the point of ligament anchorage to the implant."

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated. The document mentions "a variety of screw/washer configurations" (four specific tests are listed) and compares them to "the currently marketed screw/washer construct." It does not specify the number of individual tests or samples conducted for each configuration.
Data provenance: The testing was conducted by MedicineLodge, Inc. (manufacturer). The data is from prospective in-house mechanical testing. The "country of origin" is not specified but is implied to be within the US, given the FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. Ground truth, in the context of this document, refers to the physical measurement of mechanical properties (yield load and mode of failure) from the testing. These are objective measurements, not subjective evaluations requiring expert consensus for ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods are typically used for subjective assessments where there might be disagreement among reviewers, which is not the case for mechanical testing results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. This is a non-AI/ML device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

This information is not applicable. This is a non-AI/ML device.

7. The type of ground truth used:

The ground truth used was mechanical testing results and observed modes of failure.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/ML device. The testing was conducted to demonstrate the performance and substantial equivalence of the physical device.

9. How the ground truth for the training set was established:

This information is not applicable. There is no "training set." The ground truth for the performance evaluation was established through controlled mechanical testing as described in the "DEVICE TESTING" section.

Summary

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JUL 30 1996

Premarket Notification

510(k) Summary of Safety and Effectiveness Information

DATE OF SUMMARY PREPARATION

June 5, 1996

MANUFACTURER

MedicineLodge, Incorporated 152 South 600 West Logan, Utah 84321 Telephone: (801) 753-7675 (801) 753-7698 Fax:

MANUFACTURER CONTACT PERSON

Wade Fallin Vice President of R&D MedicineLodge, Inc. 152 South 600 West Logan, Utah 84321 Telephone: (801) 753-7675 (801) 753-7698 Fax:

PROPRIETARY NAME

MedicineLodge, Inc. (MLI) Soft Tissue Screw and Washer System

COMMON NAMES

Orthopedic Bone Screw Orthopedic Washer

CLASSIFICATION NAME

Non-degradable Soft Tissue Fastener

CLASSIFICATION REFERENCE

Currently, no FDA classification exists for Non-degradable Soft Tissue Fasteners

DEVICE PRODUCT CODE

MBI

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CLASSIFICATION PANEL

Orthopedic and Rehabilitation Devices

PROPOSED REGULATORY CLASS

In accordance with FDA classification of fixation bone screws and orthopedic washers as Class II medical devices, this device system is proposed for placement in Class II.

REASON FOR PREMARKET NOTIFICATION

The MLI Soft Tissue Screw and Washer System is a new medical device proposed for placement in Class II.

SPECIAL CONTROLS

At this time, Food and Drug Administration generated Performance Standards applicable to MedicineLodge, Inc. Soft Tissue Screws and Washers are not in force. However, MedicineLodge, Inc. has conducted mechanical testing on four screw/washer configurations to demonstrate the substantial equivalence of the device. Additionally, MedicineLodge, Inc. utilizes materials and vendor certifications, in-house standard operating procedures (SOP's), and ASTM standards, as appropriate.

INDICATIONS FOR USE

SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES

MedicineLodge, Inc. believes that several commercially available devices are substantially equivalent to the MLI Soft Tissue Screw and Washer System. Within the proposed class, the following devices are used as predicate devices for comparison:

Linvatec Concept Soft Tissue Anchoring Implants 1) Linvatec, Inc.; Largo, FL
Arthrotek Ligament Screw System 2) Arthrotek, Inc., Ontario, CA
1. Mitek Screws and Washers Mitek Surgical Products, Inc .; Norwood, MA

MedicineLodge, Inc. believes that the information presented below demonstrates the substantial equivalence of the MLI Soft Tissue Screw and Washer System when compared to the above selected predicate devices.

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SUBSTANTIAL EQUIVALENCE COMPARISON

To begin, the materials, method of manufacture, method of sterilization, and device packaging for all MLI Soft Tissue Screw and Washer System components are equivalent to those used for the selected predicate devices.

MLI Soft Tissue Screws and Washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures. The previously listed predicate device systems are similarly indicated for procedures involving soft tissue reconstruction.

The MLI Soft Tissue Screws and Washers are designed to be used as an assembly unit. The MLI Soft Tissue Anchoring Screws are provided in standard sizes, as tabulated below:

Screw Diameter	Screw Length
4.5 mm (Cortical)	30 mm - 60 mm, in 2 mm increments
6.5 mm (Cancellous)	20 mm - 55 mm, in 5 mm increments- Frances of the contract of the contribution of the many of the may be interest of the may be the may be the may be the may be the may

MLI Screws are equivalent in design to currently marketed standard bone screws, with all threads and defining screw features conforming to ISO 5835, Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Assymetrical Thread Dimensions. The screws are self-tapping and are designed to be manually inserted using a standard 3.5 mm hex driver. Engineering Drawings are provided in Exhibit I for reference.

The MLI Washers are designed to be universally compatible with both the 4.5 mm and 6.5 mm MLI Screws and are provided in the three following design configurations to allow the surgeon a variety of washers to choose from:

Washer Shape	Washer Diameter
Round	14 mm, 17 mm, 20 mm
Triangular	17.5 mm, 20.5 mm
Oval	19 mm, 22 mm

The washers possess spikes spaced equidistant from each other on the distal side of the washer to penetrate the host bone and thus anchor the graft in place. Engineering drawings of the washers are also provided in Exhibit I for reference.

Although the washer design configurations listed above may vary slightly from standard washers used in soft tissue repair, testing performed by MedicineLodge, Inc. shows that these differences do not compromise the performance of the washers relative to standard round washers in their intended clinical use. This testing is discussed below.

DEVICE TESTING

MedicineLodge, Inc. has conducted device testing on a variety of screw/washer configurations to assess the performance of the MLI Soft Tissue Screw and Washer

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System. These results were then used compare the performance of the MLI Screws and Washers to a commercially marketed soft tissue screw and washer system.

The following tests were conducted using the indicated screw/washer combinations:

(i) Test #1: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Small Round Washer (13 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
(ii) Test #2: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Large Round Washer (18 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
(iii) Test #3: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Trianqular Washer (11.5 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
(iv) Test #4: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Football Washer (11.5 mm x 8.5 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.

The mode of failure for all MLI Screw and Washer configurations was similar for all screw/washer constructs tested, wherein the ligament pulled out from under the washer. The modes of failure are also consistent with results obtained by Matthews et.al and Kurosaka et.al where the site of failure was at the point of ligament anchorage to the implant. It is important to note that yield of the graft construct results in permanent deformation of the ligament, which can in turn result in a loose or lax graft. For this reason, MedicineLodge, Inc. believes that the yield load data best measures the observed mode of failure.

When the vield load results for the various MLI Soft Tissue Screw and Washer System screw/washer constructs were compared to the currently marketed screw/washer construct, the MLI screw/washer constructs all performed as well or better than the predicate screw/washer construct.

It is important to state that the washer sizes that will comprise the MLI Soft Tissue Screw and Washer System will be larger than those tested. The thus increases the distal surface area of the washers, which in turn should result in increased fixation strength of the graft construct in true clinical application of the product. In particular, for the Football washer (tested size: 11.5mm; marketed sizes: 19mm and 22mm), this size increase should provide additional assurance that the device will perform equivalent to the predicate screw/washer construct.

It is our belief that these results confirm the equivalence of the MLI Soft Tissue Screw and Washer System relative to the tested predicate device in testing devised to simulate clinical application of the product,

CONCLUSION

Based on the design concept, indications for use, use of standard materials, and feature comparisons to the selected predicate devices, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that MLI Soft Tissue Screw and Washer System is

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substantially equivalent to existing legally marketed soft tissue anchor screw and washer systems.

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Table 1 on the following page summarizes the relevant feature comparisons between the MLI Soft Tissue Screw and Washer System and the selected predicate devices.

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TABLE 1

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Feature comparisons between the MedicineLodge, Inc. Soft Tissue Anchoring Screw and a selected predicate device system (differences are indicated in bold print).

	MLI Soft Tissue Screwand Washer System	Mitek Screws andWashers	Linvatec Concept SoftTissue Anchoring Set	Arthrotek LigamentScrew and WasherSystem
Indications	MedicineLodge, Inc. soft tissuescrews and washers are indicatedfor use in soft tissue graftfixations to the femur or tibia, orboth, during cruciate ligament,tendon or other soft tissue graft(e.g. semitendinosus) repairprocedures.	Mitek screws and washers areused to attach ligaments,tendons and other soft tissue tobone.	Concept soft tissue screws andwashers are used to attachligaments, tendons and othersoft tissue to bone.	Arthrotek Ligament Screw andWasher system is designed toproduce an efficient surgicalprocedure for iliotibial tenodesisin anterior cruciatereconstruction.
Materials	Ti6Al4V ELI (per ASTM F-316)	Ti6Al4V ELI (per ASTM F-316)	Ti6Al4V ELI (per ASTM F-316)	Ti6Al4V ELI (per ASTM F-316)
Cortical Screws	Length: 30 mm to 60 mm, in 2mm incrementsOuter Diameter: 4.5 mm	Length: 26 mm to 76 mm, in 2mm incrementsOuter Diameter: 4.5 mm	Length: 30 mm to 45 mm, in 5mm increments; 50 mm to 70mm with smooth proximal shank,in 10 mm increments.Outer Diameter: 3.5 mm	Length: 30 mm to 80 mm, in 2mm incrementsOuter Diameter: 4.5 mm
Cancellous Screws	Length: 20 mm to 55 mm, in 5mm incrementsOuter Diameter: 6.5 mm	Length: 20 mm to 50 mm, in 5mm incrementsOuter Diameter: 6.5 mm	Not Listed	Length: 25 mm to 55 mm, in 5mm incrementsOuter Diameter: 6.5 mm
ISO Conformance ofScrew Design	Yes	Yes	Yes	Yes
Screw Head Profile	Low profile	Low Profile	Low Profile	Low Profile
Surface Finish	Satin Texture	Satin Texture	Satin Texture	Satin Texture
Tapped/Self-tapping	Self-tapping	Self-tapping	Self-tapping	Tapped hole
Method of Insertion	3.5mm Hex Driver	2.5mm Hex Driver	3.5mm Hex Driver	2.5mm Hex Driver
Washers	Round: 14mm, 17mm, 20mmTriangular (Delta): 17.5mm,20.5mmOval (Football): 19mm, 22mm	Round: 14mm, 17mm, 20mm	Round (with post): 14mm,17mm, 20mmRound (Flat Washers): 14mm,17mm	Round: 14mm, 18mm
Suture Holes in Washer	No	No	Yes	Yes
Imbrications on DistalSurface of Washer	Yes	Yes	No	No
Sterilization Status	Sterile & Non-sterile	Sterile & Non-sterile	Sterile & Non-sterile	Sterile & Non-sterile
Manufacturer	MedicineLodge, Inc.	Mitek Surgical Products, Inc.	Linvatec, Inc.	Arthrotek, Inc.
Currently Marketed?(Presumed 510(k) Approved)	N/A	Yes	Yes	Yes

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.